MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM96200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: (b)(6).
Event or Problem Description
Same procedure as 2134265-2018-60934.It was reported cardiac tamponade occurred.An intellamap orion mapping catheter and intellatip mifi oi ablation catheter were selected for use during an atrial fibrillation ablation procedure.After isolation of both pulmonary veins, atrial tachycardia of the right atrium occurred and mapping was completed.When ablation was started, blood pressure decreased due to cardiac tamponade.Three hundred cc of blood were drained.After the bleeding was successfully stopped, ablation was completed successfully without issue.It was not determined which catheter the event was related to; the physician believed the tamponade was due to left atrial damage during ablation or during brockenbrough.There had been no resistance while maneuvering the catheter and there were no device issues during the procedure.The patient was stable with a good outcome.
Additional Manufacturer Narrative
Weight: (b)(6).
Event or Problem Description
Same procedure as 2134265-2018-60934.It was reported cardiac tamponade occurred.An intellamap orion mapping catheter and intellatip mifi oi ablation catheter were selected for use during an atrial fibrillation ablation procedure.After isolation of both pulmonary veins, atrial tachycardia of the right atrium occurred and mapping was completed.When ablation was started, blood pressure decreased due to cardiac tamponade.Three hundred cc of blood were drained.After the bleeding was successfully stopped, ablation was completed successfully without issue.It was not determined which catheter the event was related to; the physician believed the tamponade was due to left atrial damage during ablation or during brockenbrough.There had been no resistance while maneuvering the catheter and there were no device issues during the procedure.The patient was stable with a good outcome.The device was received for analysis.Tip motion was evaluated; both the right and left curves passed the test.Continuity checks revealed no electrical opens or shorts.All electrodes, sensor, and thermocouple resistance measurements were within specification.The steering knob and tension control knob functioned properly in both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Ablation was verified; no error codes, warnings or alarms occurred and the device was found within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 7882384
• Report Number: 2134265-2018-60936
• Device Sequence Number: 1819272
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022315782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR